Glenveigh Medical, a privately-held life science and technology company, announced Thursday that the U.S. Food and Drug Administration (FDA) has designated Digoxin Immune Fab (DIF), a potential new therapy the company is developing to treat severe preeclampsia, for Fast Track review.
The FDA has designated DIF for Fast Track review to help facilitate further development and expedite its review. The main purpose of the Fast Track designation is to get important new drugs to patients earlier. Fast Track addresses a broad range of diseases considered serious and lacking adequate treatment options.
DIF has been acknowledged by the FDA as having the potential to provide a therapy where none exists. Currently, there are only medications to treat the symptoms of preeclampsia, not the underlying causes of the disease.
Preeclampsia is a dangerous and rapidly-progressive hypertensive disorder of pregnancy that affects up to 320,000 women annually in the United States, making it the leading cause of maternal death in the country. Preeclampsia often creates a complex medical scenario, where clinicians must balance the health of the mother and baby simultaneously. Early delivery is the most effective treatment, but can have dire consequences for the infant.
“For women with severe preeclampsia, DIF is taking treatment to a level that hasn’t been available before,” said Dr. David Adair, founder and chairman of Glenveigh Medical. “In particular, for women at an early gestation, DIF can potentially stabilize their condition, as well as improve fetal and neonatal outcomes. These babies have very high death rates and, when they do survive, have increased risks of significant adverse neurological and learning difficulties. Anything that could positively impact this perinatal period would translate into huge gains for society’s most fragile citizens.”
Dr. Adair, a maternal fetal medicine specialist, began research into preeclampsia almost two decades ago. Through Dr. Adair and his team’s research on this urgent and unmet medical need, Glenveigh received orphan drug designation for DIF from the FDA earlier this year. Orphan drug status is given to the development of drugs meant to treat rare diseases and conditions for which adequate treatments have not been available. DIF’s Fast Track designation is another milestone in the development process. As many as 30 sites across the country could be involved in the upcoming pivotal study.
“We certainly understand there’s an unmet medical need for preeclampsia and eclampsia treatment,” said Eleni Tsigas, executive director of the Preeclampsia Foundation. “The Fast Track designation is significant for expediting Glenveigh’s research and development work to help determine if this could be a safe and effective therapy for this dangerous disorder."